Alka-Seltzer Plus Cold and Flu, Alka-Seltzer Plus Cold and Flu, Basix, Alka-S...

Description

Alka-Seltzer Plus® is an effervescent tablet formulation designed for the relief of severe cold and flu symptoms. The product features a citrus flavor and utilizes the proprietary POWERFAST FIZZ™ technology to enhance dissolution and absorption. Each tablet contains a combination of active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; chlorpheniramine maleate, an antihistamine; dextromethorphan HBr, a cough suppressant; and phenylephrine hydrochloride, a nasal decongestant.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or flu, including minor aches and pains, headache, cough, sore throat, runny nose, sneezing, and nasal and sinus congestion. Additionally, it temporarily reduces fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 tablets fully dissolved in 4 ounces of water every 4 hours as needed. The total daily dosage should not exceed 8 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

The use of this medication is not recommended for children under 12 years of age. It is imperative that patients adhere to the recommended dosage and frequency to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. This is due to potential interactions that may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• Individuals with a history of allergic reactions to this product or any of its components should not use it, as this may lead to severe allergic responses.

• The product is not recommended for use in children under 12 years of age, as safety and efficacy have not been established in this population.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, this product should not be used to sedate children.

Patients should refrain from using this product under the following circumstances:

• If they are currently taking any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, patients should consult a doctor or pharmacist.

• If they are taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for two weeks after discontinuing such medication. Patients should verify with a healthcare provider if they are unsure whether their prescription includes an MAOI.

• If they have a history of allergic reactions to this product or any of its components.

• In children under 12 years of age.

In cases of overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a doctor if any of the following occur:

• Pain, cough, or nasal congestion worsens or persists beyond seven days.

• Fever worsens or lasts more than three days.

• Redness or swelling is observed.

• New symptoms develop.

• Cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

• Symptoms of nervousness, dizziness, or sleeplessness arise.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses. The product contains acetaminophen, which can lead to severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen in a 24-hour period, using it in conjunction with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Severe allergic reactions have been reported, which may manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. In the event of any skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, a sore throat warning is in place; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Common adverse reactions associated with this product include marked drowsiness, which may be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Patients are cautioned to avoid alcoholic beverages and to exercise caution when driving or operating machinery due to the potential for increased drowsiness. In children, excitability may occur.

Patients should discontinue use and consult a doctor if any of the following occur: pain, cough, or nasal congestion worsens or lasts more than seven days; fever worsens or lasts more than three days; redness or swelling is present; new symptoms develop; or if a cough returns or occurs with a rash or headache that persists, as these may indicate a serious condition. Additionally, if nervousness, dizziness, or sleeplessness occurs, patients should seek medical advice.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding due to potential interactions.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation and potential respiratory depression is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Cold and Flu, Alka-Seltzer Plus Cold and Flu, Basix, Alka-Seltzer Plus Cold and Flu, Cvp (chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is contraindicated for sedation in children. Healthcare professionals should advise caregivers to consult a doctor prior to use if the child has a breathing problem, such as emphysema or chronic bronchitis, or if there is a persistent or chronic cough associated with conditions like smoking, asthma, or emphysema.

Excitability may occur, particularly in pediatric patients. In the event of an overdose, it is crucial to seek immediate medical attention for children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not require specific dosage adjustments when receiving this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of this product. Notable reactions include severe skin reactions, which encompass skin reddening, blisters, rash, hives, and facial swelling. Additionally, cases of asthma, characterized by wheezing, and instances of shock have been reported. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to ask their healthcare provider if they are unsure whether their prescription includes an MAOI.

It is important to inform patients not to use this product if they have a history of allergic reactions to it or any of its ingredients. Furthermore, this product is not recommended for children under 12 years of age.

Patients should be instructed to stop using the product and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than seven days, or if their fever worsens or lasts more than three days. They should also seek medical advice if they notice any redness or swelling, experience new symptoms, or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition. Additionally, patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

While using this product, patients must not exceed the recommended dosage. They should be made aware that the product may cause marked drowsiness and should avoid alcoholic beverages during its use. Patients should also be cautioned that alcohol, sedatives, and tranquilizers may enhance drowsiness. Care should be taken when driving a motor vehicle or operating machinery, as excitability may occur, particularly in children.

Patients with specific health conditions should be advised to consult a doctor before using this product. These conditions include liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to prostate enlargement, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), and those on a sodium-restricted diet. Additionally, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should seek guidance from their doctor or pharmacist before use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Cold and Flu, Alka-Seltzer Plus Cold and Flu, Basix, Alka-Seltzer Plus Cold and Flu, Cvp, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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